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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05675137
Other study ID # 2022-03-013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2022
Est. completion date October 28, 2022

Study information

Verified date January 2023
Source Silvia Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 28, 2022
Est. primary completion date October 28, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility Inclusion Criteria: 1. experiencing subjective cognitive decline, 2. had a smart phone and could use it, and 3. understood the purpose and process of this study. Exclusion Criteria: 1. major psychiatric disorders 2. dementia, 3. degenerative brain diseases 4. severe or unstable heart diseases 5. neurological or psychological diseases that affected cognitive functioning 6. severe vision or hearing impairment, 7. current participation in a cognitive training program 8. does not know how to use mobile devices.

Study Design


Intervention

Device:
mobile-based
Participants who were randomly assigned to the mobile-based intervention group were provided multidomain programs based on scientific evidence of ways to improve brain-health and reduce dementia risk for 10 minutes per day and at least 50 minutes per week.
Other:
paper-based
Participants who were randomly assigned to the paper-based intervention group were provided with the Korean version of the dementia prevention booklet published by the WHO.

Locations

Country Name City State
Korea, Republic of Silviahealth Seoul

Sponsors (2)

Lead Sponsor Collaborator
Silvia Health Chosun University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks Cognitive function baseline and after the 12-week intervention
Secondary Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks Cognitive function baseline and after the 12-week intervention
Secondary Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks Self-reported memory failures baseline and after the 12-week intervention
Secondary Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks Depression baseline and after the 12-week intervention
Secondary Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks Anxiety baseline and after the 12-week intervention
Secondary Change from baseline Perceived Stress Scale (PSS) at 12 weeks Stress baseline and after the 12-week intervention
Secondary Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks Health-related Quality of life baseline and after the 12-week intervention
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